Effect of study partner on the conduct of Alzheimer disease clinical trials
ABSTRACT OBJECTIVE: Alzheimer disease (AD) dementia clinical trials require 2 participants: a patient and a study partner. We assessed the prevalence of study partner types and how these types associate with patient-related outcome measures. METHODS: Retrospective analyses of 6 Alzheimer's Disease Cooperative Study (ADCS) randomized clinical trials were conducted. Study partners were categorized as spouse, adult child, or other. Prevalence of study partner type and associations between study partner type and trial outcomes including study completion and placebo decline on the Mini-Mental State Examination, the Alzheimer's Disease Assessment Scale-cognitive subscale, the Clinical Dementia Rating scale Sum of the Boxes score, and the ADCS-Activities of Daily Living were examined. RESULTS: More participants (67%) enrolled with spouses than adult children (26%) or other study partners (7%). Participants with spouse partners had a lower dropout rate (25%) than those with adult child (32%) or other study partners (34%); only the difference vs others was statistically significant. Participants with adult child and other partners randomized to placebo performed worse at baseline than those with spouse partners on the ADCS-Activities of Daily Living (p = 0.04), but were not different at 18 months. There were no differences at baseline for the Mini-Mental State Examination, Clinical Dementia Rating scale Sum of the Boxes score, or Alzheimer's Disease Assessment Scale-cognitive subscale. In multivariate models of the rates of change over time among placebo participants, no differences among study partner groups reached statistical significance. CONCLUSIONS: Patients with nonspouse caregivers less frequently participate in AD dementia trials. Increased enrollment of AD patients with nonspouse caregivers may require additional recruitment and retention strategies.
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ABSTRACT: A recent national survey of HIV+ adults noted that nearly three-quarters of cognitively impaired individuals are categorized as having Asymptomatic Neurocognitive Impairment (ANI), lacking documented compromise of everyday function. The clinical impact and long-term consequences of ANI are unknown and the importance of this asymptomatic diagnosis has raised concerns in clinical care settings where competing priorities often exist. In this study, we conducted structured tests of everyday functioning in a sample of HIV+ subjects over 60 years of age and asked subjects to rate their performance relative to peers. We demonstrate that individuals with neuropsychological testing impairment often lack self-awareness of functional performance deficits. Specifically, ANI subjects rated functional performance similar to that of HIV-negative control subjects, despite noted deficits in objective measures of function. These findings have important implications for use of self-report of function in the diagnosis of HIV-associated Neurocognitive Disorders (HAND), likely underestimating symptomatic impairment.AIDS research and human retroviruses 02/2013; 29. DOI:10.1089/AID.2012.0229 · 2.46 Impact Factor
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ABSTRACT: To describe strategies, culled from experience, for responding to several recruitment challenges in an ongoing randomized clinical trial of delirium in persons with dementia. Delirium in people with dementia is common across all cultures. Little research supports the use of specific interventions for delirium. Recruitment of an adequate sample is critical to the validity of findings from intervention studies that form the foundation for evidence-based practice. The trial referenced in this article tests the efficacy of cognitive stimulation for resolving delirium in people with dementia. Participants are recruited at the time of admission to one of eight community-based skilled nursing facilities (SNFs). Eligible participants are 65 years of age or older and community dwelling, and have a diagnosis of dementia and delirium. Recruitment challenges and strategies were identified during weekly team meetings over a 2-year period. Recruitment challenges include factors in the external and internal environment and the participants and their families. Strategies that address these challenges include early site evaluation and strong communication approaches with staff, participants, and families. The recruitment of an adequate sample of acutely ill older adults with dementia in SNFs can pose a challenge to investigators and threaten the validity of findings. Recruitment strategies that help improve the validity of future studies are described. Worldwide, over 100 million people will have dementia by 2050, placing them at increased risk for delirium. Recruitment strategies that improve the quality of nursing research and, by extension, the care and prevention of delirium in older adults with dementia during rehabilitation in SNFs are greatly needed.Journal of Nursing Scholarship 07/2013; 45. DOI:10.1111/jnu.12042 · 1.77 Impact Factor
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ABSTRACT: Most patients with Alzheimer's disease (AD) do not have a spouse. Despite this, the majority of AD research participants enroll with a spouse study partner. It remains unclear if differences between AD patients who do and do not have a spouse may bias study results. In this study, we examined whether AD patients with different study partner types (spouse versus adult child) demonstrate different rates of disease progression over two years on three outcome measures commonly used in AD research, including clinical trials. We used data from the National Alzheimer's Coordinating Center Uniform Data Set to examine disease progression in participants age 55-90 with probable AD dementia. We examined disease progression as measured by the Clinical Dementia Rating Scale-Sum of the Boxes score, the Mini Mental Status Examination, and the Functional Assessment Questionnaire. Analyses were performed on data for all available eligible participants from the NACC UDS and after performing a propensity-matching model to better account for inherent differences between the populations of interest. Propensity matching was successful only when models did not include age and gender. For both propensity-matched analyses and those of all available data, we did not observe any differences between the study partner populations for any outcome measure. These results suggest that if investigators can improve in recruiting AD patients with adult child caregivers to research, the implications to study results may be minimal.Journal of Alzheimer's disease: JAD 08/2013; 38(3). DOI:10.3233/JAD-131052 · 4.15 Impact Factor